Personnel

1. Basic Principles of GMP Personnel 9

2. Personnel Objectives • To review general issues related to personnel • To review requirements for key personnel • To review the training of personnel • To consider some specific issues

3. Personnel Principle • A satisfactory system of QA, manufacture and control of products and APIs rely on people. • Must be sufficient qualified personnel to carry out tasks • Individual responsibilities must be clearly defined and understood by individuals concerned • Written job descriptions • All personnel should be aware of the principles of GMP that affect them 9.1

4. Personnel General (1) Personnel requirements: • Adequate number of persons • With necessary qualifications • With practical experience • An individual’s responsibilities should not be so extensive as to present a risk to quality 9.2

5. Personnel General (2) • Specific duties in written job descriptions • Adequate authority to carry out responsibilities • May delegate to designated deputies with qualifications • No gaps or unexplained overlaps • Authorized organization chart 9.3

6. Basic Principles of GMP Organization chart • This is NOT what it should look like

7. Personnel General (3) • All personnel should be aware of GMP • Must receive training in GMP: • initial training • continuing training • including hygiene standards • Motivated to • support the establishment • maintain high-quality standards 9.4

8. Personnel General (4) • Prevent unauthorized access to: • Production areas • Storage areas • Quality control • Stop personnel who do not work in these areas using them as passageways 9.5

9. Basic Principles of GMP

10. Personnel Key Personnel (1) Key personnel (which normally should be full-time) positions and include: • Authorized person • Head of Production • Head of Quality Unit • Quality Assurance and Quality Control • May delegate functions – not responsibility • Heads of Production and Quality Unit should be independent of each other 9.6

11. Personnel Key Personnel (2) Should have appropriate qualifications • Scientific education such as: • chemistry or biochemistry • chemical engineering • microbiology • pharmaceutical sciences and technology • pharmacology and toxicology • physiology; or • other related science subjects relevant to the responsibilities to be undertaken 9.7

12. Personnel Key Personnel (3) Should have appropriate experience • Practical experience • Manufacture and quality assurance • Preparatory period under professional guidance sometimes needed • Education and experience should enable personnel to take difficult decisions in an independent, professional and scientific way • resolve the problems encountered in manufacturing and QC 9.7

13. Personnel Shared Responsibilities (1) Heads of Production and Quality Unit may share/jointly exercise some responsibilities relating to quality e.g.: • authorization of written procedures (SOPs) and other documents • monitoring and control of manufacturing environment • hygiene • process validation and calibration • training, including application and principles of QA • approval and monitoring of suppliers and contract acceptors 9.8

14. Personnel Shared Responsibilities (2) • Designation and monitoring of storage conditions for materials and products • Performing and evaluating in-process controls • Retention of records • Monitoring compliance with GMP • Inspection, investigation, and taking of samples to monitor factors which may affect quality 9.8

15. Personnel Head of Production: Responsibilities (1) • Product production and storage according to appropriate documentation • Approval and implementation of production instructions, in-process QC and ensure strict implementation • Ensures that production records are evaluated and signed by designated person 9.9

16. Personnel Head of Production: Responsibilities (2) • Checks maintenance of production department, premises and equipment • Ensures process validation and calibration performed, recorded, and reports are made available • Ensures initial and continuous training of production personnel 9.9

17. Personnel Head of Quality Unit: Responsibilities (1) • Approve or reject starting materials, packaging materials, and intermediate, bulk and finished products in relation with their specifications • Evaluate batch records • Ensure that all necessary testing is carried out • Approve sampling instructions, specifications, test methods and other QC procedures 9.10

18. Personnel Head of Quality Unit: Responsibilities (2) • Approve and monitor analyses carried out under contract • Maintenance of the department, premises and equipment • Validations (including analytical procedures) and calibrations of control equipment are carried out • Initial and continuing training of quality unit personnel 9.10

19. Personnel Head of Quality Unit: Responsibilities (3) • Establishment, implementation and maintenance of the quality system • Supervision of the regular internal audits or self-inspections • Participation in external audit (vendor audit) • Participation in validation programmes (See also other duties of QC later) 9.10

20. Personnel Authorized person: Responsibilities (1) • Compliance with technical and regulatory requirements • Approval of the release of finished product for sale • Function may be delegated to another person (e.g. QA) • In some countries, overall responsibility including • The establishment and implementation of quality system • Development of quality manual • Supervision of self-inspections and quality audits 9.11, 9.15

21. Personnel Authorized person: Responsibilities (2) • No batch of product is to be released for sale or supply prior to certification by the authorized person(s). • Assessment of finished product include: • Review of production conditions • Results of in-process testing • Manufacturing (including packaging) documentation • Compliance with specifications • Examination of the finished pack 9.12, 9.13

22. Personnel Person releasing the batch should ensure: (1) • Each batch meets manufacturing and marketing authorization requirements • Principles and requirements of GMP are met • All checks and tests have been performed • Production conditions and manufacturing records • Planned changes and deviations reported - includingwhere necessary to drug regulatory authority 9.14 a - e

23. Personnel Person releasing the batch should ensure: (2) • Additional sampling, inspection, checks and tests had been done when required • All production and control documents are completed and endorsed • Audits, inspections and spot-checks were done • QC approval has been given • All other relevant factors have been considered 9.14 f - j

24. Personnel Training (1) • Training, in accordance with a written, approved programme • all personnel whose duties take them into production areas; • into control laboratories; and • for others whose activities could affect the quality of the product including technical, maintenance and cleaning personnel • Induction and continuing training • on theory and practice of GMP and their duties • training records should be kept • practical effectiveness checked • training before undertaking any new task 10.1, 10.2

25. Personnel Training (2) • Specific training for staff in special areas, e.g. • Where contamination is a hazard • Clean areas • Areas where highly active, toxic, infectious, sensitizing materials are handled • The concept of QA - ensure understanding and its implementation 10.3, 10.4

26. Personnel Visitors or Untrained Personnel Should not to enter production and control areas. If this is unavoidable then: • They must be given information in advance: • GMP • personal hygiene • protective clothing requirements • Behaviour (no samples to be taken, touching etc.) • Must be accompanied and closely supervised at all times 10.5

27. Personnel Consultants and contract staff • Should be qualified for the services provided • Training records maintained • Records should prove qualifications 10.6

28. Personnel Group Session • What do you think will be the key personnel issues to arise during an inspection? • What sort of responses do you think you should give to these issues when they become apparent?

29. Personnel Possible Issues – I • Limited number of staff • Inadequate qualifications • Inadequate experience • Owner interferes in quality decisions • Lack of means to develop training materials

30. Personnel Possible Issues – II • Company procedures take precedence over local legislation • Unclear organization diagram • Staff movement • Inadequate training records • Illness